Big Data in FDA-Regulated Industry: How to Identify, Use & Benefit from It

Event Information
Product Format
Prerecorded Event
Dr. David Lim, Ph.D., RAC, ASQ-CQA
Conference Date
Wed, Jul 11, 2018
60 minutes
Product Description

Learn How to Identify and Apply Big Data Insights to Your FDA-Regulated Business

Now available in public domain, big data (information) has the potential to transform healthcare, like it has revolutionized other industries. It has now become critical to use big data in any FDA-regulated industry – for reducing cost, improving patient outcomes and saving lives. Healthcare stakeholders that take the lead in investing in big-data initiatives will not only gain competitive advantage but also save significantly on resources.

In this webinar, industry veteran David Lim will discuss practical, actionable and sustainable approaches to help FDA-regulated industry benefit from big data applications. Lim will show you how to most effectively identify and apply big data insights to your FDA-regulated business (drugs and medical devices including IVDs, dietary supplements, cosmetics, etc.).

Lim will share his best practices – including dos, don’ts and tips that help you save time, energy and money by strategically applying big data insights to your business practices.

This presentation is a must for you if you’re a regulatory professional working in any FDA-regulated healthcare industry – including drugs, biologics, biosimilars, medical devices and IVDs, combination products, etc.

After attending this webinar, you will learn how to develop and implement best practices to systematically use and benefit from big data.

Session Highlights

This session will bring you up to speed with:

  • Applicable laws, regulations, and guidance
  • Big data sources in pharmaceuticals and medical devices
  • Power of big data
  • Data mining and safety data
  • Solving big problems using big data
  • Science of using big data
  • Big data, security and privacy matters
  • Revolution in FDA-regulated industry using big data
  • Company’s views on big data
  • Big Data: current trends and big data driven medicines
  • Big Data: legal, ethical and policy issues
  • Failure to use big data
  • Inadequate use of big data
  • Big data management: challenges and opportunities
  • Post-marketing surveillance
  • Systematic use of big data: best practices
  • Speaker’s PASS-IT suggestions/recommendations
  • Speaker’s experience and actual cases
  • Conclusion

Who Should Attend

  • CEOs
  • VPs
  • Compliance officers
  • Attorneys
  • Regulatory affairs
  • Clinical affairs
  • Quality assurance
  • R&D
  • Consultants
  • Contractors/subcontractors
  • Anyone interested in the use of Excel spreadsheet under FDA regulatory environment

Ask a question at the Q&A session following the live event and get advice unique to your situation, directly from our expert speaker.

Order Below or Call 1-844-384-4744 Today

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About Our Speaker

Dr. David Lim - FDA Medical Device  Regulation Expert

Dr. David Lim, Ph.D., RAC, ASQ-CQA. Dr. Lim is President and Principal of Regulatory Consulting Firm, Regulatory Doctor ( As a leading industry speaker, Dr. Lim frequently presents various topics in areas of FDA regulatory, clinical, quality and regulatory compliance matters in various forums and meetings.

Dr. Lim has helped both pharma and medical device industry for regulatory, clinical and compliance...   More Info
More Events By The Speaker

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